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NCT00176930 · OUTCOME

Number of Participants With Acute Graft-versus-host Disease (GVHD)

Stem Cell Transplant for Hematological Malignancy · Source last updated 2021-01-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 100

What was measured

Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host. Determine the incidence of grade II-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Groups in this outcome

PBSC: No TBI

Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant

Marrow : No TBI

Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant

UCB : No TBI

Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant

UCB : No TBI/Bu/Cy/ATG

Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen

PBSC

Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant

Marrow

Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant

Umbilical Cord Blood

Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant

Co-Enroll From MT0403

Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
PBSC: No TBI12
Marrow : No TBI13
UCB : No TBI1
UCB : No TBI/Bu/Cy/ATG1
PBSC213
Marrow85
Umbilical Cord Blood2
Co-Enroll From MT04032

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PBSC: No TBI6Not reportedNot reportedNot reportedNot reported
Marrow : No TBI2Not reportedNot reportedNot reportedNot reported
UCB : No TBI1Not reportedNot reportedNot reportedNot reported
UCB : No TBI/Bu/Cy/ATG0Not reportedNot reportedNot reportedNot reported
PBSC89Not reportedNot reportedNot reportedNot reported
Marrow23Not reportedNot reportedNot reportedNot reported
Umbilical Cord Blood0Not reportedNot reportedNot reportedNot reported
Co-Enroll From MT04030Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        89
      6. group Id
        OG005
        value
        23
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      13
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      213
    6. group Id
      OG005
      value
      85
    7. group Id
      OG006
      value
      2
    8. group Id
      OG007
      value
      2
    units
    Participants
description
Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host. Determine the incidence of grade II-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
groups
  1. description
    Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant
    id
    OG000
    title
    PBSC: No TBI
  2. description
    Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant
    id
    OG001
    title
    Marrow : No TBI
  3. description
    Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant
    id
    OG002
    title
    UCB : No TBI
  4. description
    Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
    id
    OG003
    title
    UCB : No TBI/Bu/Cy/ATG
  5. description
    Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
    id
    OG004
    title
    PBSC
  6. description
    Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
    id
    OG005
    title
    Marrow
  7. description
    Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
    id
    OG006
    title
    Umbilical Cord Blood
  8. description
    Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    id
    OG007
    title
    Co-Enroll From MT0403
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Day 100
title
Number of Participants With Acute Graft-versus-host Disease (GVHD)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice